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A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto – CPAP for Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00254059
First received: November 10, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

This study will look at an alternative new pathway for diagnosis and treatment based on simple procedures in the patient’s own home compared with the current conventional laboratory based pathway. The purpose is to determine whether all patients with OSA require the more elaborate laboratory procedures, or whether a subgroup can be managed more simply.


Condition Intervention
Obstructive Sleep Apnea
 Procedure: Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto – CPAP for Diagnosis and Nasal CPAP Titration in Patients With a High Probability of Obstructive Sleep Apnea.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome measurement will be apnea-hypopnea index (AHI) during a full night polysomnogram performed on the effective nasal CPAP pressure after 3 months of nasal CPAP therapy.

Secondary Outcome Measures:
  • 1. The study will also compare CPAP pressure between the two groups after 3 months of therapy.
  • 2. This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between the two groups after 3 months of therapy.
  • 3. This study will compare Sleep Apnea Quality of Life Index between the two groups after 3 months of therapy.
  • 4. It will compare the change in Sleep Apnea Quality of Life Index from baseline to follow-up between the two groups.

Estimated Enrollment: 60
Estimated Study Completion Date: December 2004
Detailed Description:

The research question we are exploring is whether the conventional approach is better in terms of successful treatment, compliance with treatment, and quality of life. There will be 2 arms to the study. Subject will be randomly assigned to either one of the following two treatment options: 1) the conventional investigation and nasal CPAP treatment pathway comprising 2 overnight sleep studies, one for diagnosis and one for determining the required level of nasal CPAP treatment 2) experimental pathway that uses a simplified home study (overnight oximetry), together with a machine that automatically adjusts the nasal CPAP pressure to the required amount, and a careful follow-up during the first 2 weeks of treatment.

Procedures: The study protocol will require the subject to complete the following procedures which are part of routine clinical practice: History and Physical Examination by a physician, Home Oximetry (This simple test involves wearing an oxygen probe gently wrapped around subject’s finger during a night’s sleep to continuously measure the amount of oxygen in blood and detect obstructions of subject’s breathing. The probe is easily applied by the subject and requires no supervision), Spirometry (simple non-invasive breathing test), Standardized Sleepiness Questionnaires, Orientation and Education regarding nasal CPAP therapy, and compliance monitoring, Overnight polysomnography (This is the procedure that requires subject to spend a night in the sleep laboratory with a variety of painless and non-invasive monitoring devices attached to the body. The purpose is to obtain detailed information about subject’s sleep quality, breathing, heart function, and body movements during sleep. Subject will be continuously monitored by a trained technologist during this procedure.). The following procedures are not routine and subject may be required to complete some or all of them depending on which pathway assigned to. Follow-up visits to the Clinic on Days 7 and 14 of nasal CPAP treatment for adjustments of nasal CPAP pressure as required (this could also be done at home), Repeat Home Oximetry as required, Quality of Life Questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age > 18 years

  • Residence in the Lower Mainland
  • History and physical examination findings compatible with OSAHS
  • Normal spirometry. (This is necessary to avoid decreased specificity of overnight oximetry attributable to underlying lung disease)
  • Epworth Sleepiness Scale > 10

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Other known disorders that cause daytime sleepiness
  • Requiring sedative/hypnotic medications
  • Psychiatric disorder
  • Life threatening co-morbidity e.g. chronic lung disease, coronary artery disease – unstable angina, recent myocardial infarction, heart failure, seizure disorder, and previous motor vehicle accident attributed to hypersomnolence
  • Language barrier
  • Inability to give informed consent
  • Contraindication to nasal CPAP therapy
  • Previous treatment of OSAHS with nasal CPAP, oral appliance therapy or corrective upper airway surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254059

Locations
Canada, British Columbia
Vancouver Coastal Health Research Institute, Respiratory Division
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Frank Ryan, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00254059     History of Changes
Other Study ID Numbers: C03-0079
Study First Received: November 10, 2005
Last Updated: November 10, 2005
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
OSAHS, OSA, CPAP, polysomnography, overnight oximetry, Obstructive sleep apnea, apnea hypopnea index, AHI, Obstructive Sleep Apnea Hypopnea Syndrome

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013